Events

Retiro De Equipo (Recall) de Human IgM kit for use on SPAPLUS

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por In Vitro Technologies Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00916-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-07
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00916-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    An investigation by in vitro technologies investigations of specific lots of human igm kit for use on spaplus have identified that the calibration stability has decreased in comparison to historical released kits. users will be able to identify when the calibration is no longer valid, as control values will fall outside of the provided acceptable limits.
  • Acción
    The Binding Site recommends the following: 1. Batch sample analysis, when possible; 2. Recalibrate the assay when QC results have deviated outside of the specified range; 3. Contact In Vitro Technologies for any further guidance or additional kit requirements; and 4. Complete the acknowledgement form supplied with the customer letter, even if you do not have any of the affected product, and return it by email to QRA@invitro.com.au

Device

Human IgM kit for use on SPAPLUS
  • Modelo / Serial
    Human IgM kit for use on SPAPLUSItem Number: TBSNK012SLot Numbers: 400872 and 407480ARTG Number: 202167
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd